Atlast Data Management Software (Dms)
510(k) K010605
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010605 | Date7 May 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CGA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
ATLAST DATA MANAGEMENT SOFTWARE (DMS) is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The device received FDA 510(k) clearance under K010605 on May 7, 2001, and is classified as a Class II device under regulation number 862.1345. It is manufactured by Amira Medical, Inc. and assigned product code CGA. The device is supplied as a software system for glucose test systems and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.
Other devices from Amira Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the ATLAST Data Management Software (DMS) used for?
The ATLAST DMS is designed to measure glucose levels quantitatively in blood and other body fluids. These measurements are critical for diagnosing and managing conditions like diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. By providing precise glucose data, the software supports clinical decision-making in carbohydrate metabolism disorders.
How is the ATLAST DMS supplied, and is it sterile?
The ATLAST DMS is supplied as a software system intended for use with glucose test systems. According to the provided data, it is not described as sterile, single-use, or reusable. This means it is a standalone software solution that interfaces with compatible glucose measurement devices rather than a physical consumable or disposable.
Is the ATLAST DMS compatible with specific glucose test systems?
The ATLAST DMS is explicitly designed to function as a software system for glucose test systems, though the exact models or brands of compatible test systems are not detailed in the provided data. It is intended to integrate with systems that require quantitative glucose measurement for clinical or diagnostic purposes, such as those used in laboratories or point-of-care settings.
What regulatory approval does the ATLAST DMS hold?
The ATLAST DMS received FDA 510(k) clearance under the reference number K010605 on May 7, 2001. It is classified as a Class II medical device under regulation number 862.1345, indicating it has been deemed substantially equivalent to a predicate device through the traditional 510(k) review process. This clearance confirms its compliance with U.S. regulatory standards for glucose measurement software.
Does the ATLAST DMS require any special handling or storage conditions?
As a software system, the ATLAST DMS does not have physical storage requirements like temperature or humidity constraints. However, it should be installed on a compatible computer system with the necessary hardware and software specifications to ensure proper functionality. The system should be kept in a secure environment to prevent unauthorized access or data corruption, though no specific sterility or environmental conditions are noted for the software itself.